Manager – External Supply Operations Quality | Pfizer | Mumbai

Job Description

External Supply Quality is responsible for the Quality management of approximately 300 contract manufacturers, packagers, and supply partners globally. The Manager has responsibility for the effective Quality Assurance Management oversight of Pfizer partners and suppliers who manufacture or package Pharmaceutical products and/or devices on behalf of PGS. This role is globally focused with partners and suppliers in multiple geographic locations.

The External Supply Quality Manager is accountable for providing quality assurance management of key contractors/suppliers for Pfizer and for assuring that the products supplied to our patients are manufactured, and tested in accordance with cGMPs, the registration file, and any additional country-specific requirements.

Works independently with minimum supervision and demonstrates the ability to prioritize work, manage multiple tasks, and to report items as required to Team Leader

Interacting with high levels of management both at contract manufacturers/suppliers and within Pfizer.

Role & Responsibilities:

• Provide effective Quality Leadership for vendor-managed products including supporting the cross-functional virtual site operating teams (VSOT).

• Lead the implementation and support of Quality Assurance/Quality Control systems for drug products, APIs, and raw and packing materials manufactured and supplied by the Contract partner/supplier.
• Develop and negotiate Quality Agreements.
• Drive the development, implementation, and continuous improvement of Quality Systems to support Pfizer’s internal and regulatory requirements.
• Proactively support Pfizer audit ( RQA) and regulatory inspections at vendors and ensure tracking of Corrective and Preventative actions (CAPA).
• Provide Quality guidance for notification to management and significant deviations at contractor sites.
• Ensure implementation of effective CAPA and quality system improvements based upon determined remediation activities.
• Prepare AQRT summaries and participate in relevant meetings.
• Lead quality risk management activities and manage mitigation plans within partners and suppliers.
• Accountable for the on-time disposition of commercial products in line with an agreed schedule.
• Provide active support for customer complaints or deviation investigations and track CAPAs accordingly to support New Product launches.
• Operates as a spokesperson for quality and spends a significant period of time developing relationships, independently negotiating, developing, and communicating Pfizer quality requirements with contract manufacturers/suppliers. He/She has significant interactions with many internal business and manufacturing organizations.

Qualification/Experience/ Skill/Knowledge:

• Masters in Pharmacy/ Science
• Min 10 years experience in Quality function including Quality Control and Product Quality Assurance experience/Gxp experience
• Experience in  interacting with external suppliers/contractors
• Experience in managing complex quality and compliance activities with a contractor/ supplier.
• Ability to prioritize work, act and work independently, and report items as required to the Team leader
• Ability to manage multiple projects and work under pressure
• Computer skill set for SAP, TrackWise, etc.
• Command of the English language with excellent verbal and written communication including presentation skills
• Demonstrated ability to manage cross-functional project

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.